Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair

Sponsor
Syneos Health
Study ID
NCT05053334
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

A single dose, double blind comparative trial to assess the pharmacokinetics, pharmacodynamics, safety and immunogenicity of 3 different products (BP11, US-Xolair and EU-Xolair) containing 150mg of Omalizumab as subcutaneous injection in healthy male volunteers.

Key Dates

Start date
Feb 16, 2022
Status verified
Feb 2023
Primary completion
Jan 10, 2024
Completion
Jan 10, 2024

Study Design

Enrollment
165 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: BP11 (Proposed biosimilar)
    Subcutaneous injection of Omalizumab developed by CuraTeQ.
  • Active Comparator: US-Xolair
    Subcutaneous injection of Omalizumab licensed for use in USA
  • Active Comparator: EU-Xolair
    Subcutaneous injection of Omalizumab approved for use in Europe.

Primary Outcome Measure

To evaluate pharmacokinetic (PK) similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair [ Time Frame: Upto 127 Days ]

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